The FDA Drug Approval Process
It helps to understand the drug approval process. First, it is very expensive to bring a drug to market ranging from $1 billion to $2.6 billion dollars per drug and pharmaceutical companies have more losers than they do winners. Secondly, the drug approval process is lengthy and takes years.
First, preclinical research is performed studying a compound on animals. Then an investigational new drug application (IND) is submitted and reviewed by the FDA before human clinical trials can begin.
Once the FDA gives the green light, the investigational drug enters several phases of clinical trials and then post-marketing approval. There are 4 phases of clinical trials.
Phase 1: Phase 1 assesses the safety of an investigational drug. Typically, the drug’s safety profile is studied on 20 to 100 healthy volunteers. This phase looks at the metabolism and excretions of a drug as well. Phase 1 takes about one year to complete.
- 70% of the drugs will move onto Phase 2 trials.
Phase 2: Phase 2 assesses the effectiveness of a drug – how well does it work. Usually 100 to 300 volunteers with the specific condition are enrolled in phase 2 studies. Phase 2 takes about 2 years to complete and will also include a placebo group for comparison. Safety and side effects are determined too.
- 33% of the drugs will move onto Phase 3 trials.
Phase 3:Â Phase 3 trials begin if the drug is show effective in the Phase 2 trial. Phase 3 trials include 300 to 3,000 patients who are monitored for drug effectiveness and further identify side effects. Different doses may be studied. Phase 3 trials take about 3 years to complete.
- 25% to 30% of the drugs go onto Phase 4
Phase 4:Â Phase 4 is also known as the post-marketing phase and begins AFTER a drug has been approved. Phase 4 is designed to gain additional information on drug safety, efficacy, or optimal use after approval. Rare side effects that may not be evident during phase 1, 2, and 3 trials can be more readily identified during the post-marketing analysis.
If we start with 100 drugs, 70 will go on to Phase 2, and one-third of those or 21 will go to Phase 3. Using 30% then 6 will be approved following Phase 3 moving onto Phase 4.
When you factor in the time to research and develop a drug and include the pre-clinical research, it can take 10 to 15 years to bring a drug to the market place.
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